The Food & Drug Administration (FDA) categorizes medical devices into three classes based on medical regulations and federal law. Class III medical devices are subject to continuing regulatory control and can only be interrogated and programmed under the supervision of licensed medical caregivers. Class III medical devices include implantable medical devices (IMDs), such as cardiac pacemakers, defibrillators, and cerebella stimulators, and certain types of external medical devices (EMDs), such as automatic external defibrillators (AEDs).
Historically, the interrogation and programming of Class III medical devices had to be performed in a clinic or hospital using FDA-regulated programmer recorders, which use inductive or, more recently, wireless telemetry, such as radio frequency (RF) telemetry, to retrieve patient data and device settings and to apply new programming. Clinic visits, though, incur time, expense, and inconvenience, even when modest. Thus, to improve patient care, patient-operable monitors, such as repeaters, were developed to enable caregivers to remotely access their patients' medical devices outside of a clinic or hospital. These monitors can remotely retrieve patient data and device settings, which are periodically delivered to a repository for caregiver consideration and archival.
Despite their convenience, patient-operable monitors are not presently permitted to program medical devices for reasons of patient safety and regulatory compliance. For instance, programming cannot be performed by a non-FDA-regulated device, so any remote programming must currently include interfacing through a device that is properly regulated. As well, some device parameters are used to test device operation in situ and can be potentially life-threatening. Consequently, these parameters must only be modified in-clinic with life safety equipment and trained medical personnel in attendance. Finally, patient consent is implied when programming is performed in-clinic, but must be explicitly secured before remote programming is attempted. Conventional approaches fail to adequately address these issues.
For instance, U.S. Pat. No. 7,060,031 issued Jun. 13, 2006 to Webb et al., discloses a system and method for remotely programming IMDs. Pending programming requests are placed in a request queue that is ordered from older to most recent request. The requests can be encrypted and assigned sequence numbers that enable a remote monitor to determine that the request is later in sequence than any earlier requests previously applied to the IMD. Webb, however, assumes fully regulated infrastructure to effect remote programming. Moreover, such an infrastructure is costly to deploy and may not be available when a physician is called upon to make programming changes.
Therefore, there is a need for an approach to performing remote medical device programming that assures both patient safety and compliance without requiring a regulated environment as the only means to specify programming.